Clinical Trials in Italy / NCT05935215
Recruiting
Phase 3
Efficacy and Safety of Switching From Anti-C5 Antibody Treatment to Iptacopan Treatment in Study Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
NCT05935215 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Atypical Hemolytic Uremic Syndrome
Study summary
The purpose of this Phase 3 study is to evaluate the efficacy and safety of iptacopan upon switching from anti-C5 antibody to iptacopan treatment in study participants with aHUS.
Eligibility
Inclusion Criteria:
* Male and female adult participants ≥ 18 years of age with diagnosis of aHUS for whom etiologies of other types of TMA and non-aHUS kidney disease have been excluded.
•. Currently on the recommended (as per label) dosage regimen of anti-C5 antibody treatment, for at least 3 months prior to entering the screening period.
* In the opinion of the investigator the participant has responded to anti-C5 antibodytreatment prior to screening and has clinical evidence of response (in absence of PE/PI) during the Screening period.
Clinical evidence of response to anti-C5 antibody treatment (in absence of PE/PI) confirmed during the Screening period by central laboratory at two visits 12 weeks apart. Clinical evidence of response is defined as:
1. Hematological normalization in platelet count ≥150 x 10\^9/L and LDH below upper limit of normal \[ULN\], and
2. Stable kidney function as defined by serum creatinine values within ±15% during the Screening period
* Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections is required prior to the start of treatment with iptacopan.
* If not received previously or if a booster is required, vaccination against Haemophilus influenzae infection, should be given, if available and according to local regulations.
Exclusion Criteria:
* History of aHUS disease relapse while on anti-C5 antibody treatment.
* eGFR \< 30 ml/min/1.73m\^2
* Active infection or history of recurrent invasive infections caused by encapsulated bacteria, i.e., meningococcus, pneumococcus (eg., N. meningitidis, S. pneumoniae) or H. influenzae.
* Participants with sepsis or active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study treatment administration.
* Kidney, bone marrow transplant (BMT)/hematopoietic stem cell transplant (HSCT), heart, lung, small bowel, pancreas, liver transplantation or any other cell or solid organ transplantation
* Female patients who are pregnant or breastfeeding, or intending to conceive during the course of the study
* Any medical condition deemed likely to interfere with the patient's participation in the study
Primary outcome measure(s)
- Percentage of participants free of TMA manifestation — 12 months
Absence of thrombotic microangiopathy (TMA) manifestation, without use of anti-C5 antibody, during the 12 months of iptacopan treatment following the switch of treatment from an anti-C5 antibody to iptacopan treatment.
Trial sites (31)
| Facility | City | Region | Status |
|---|---|---|---|
| Novartis Investigative Site | Nanjing | Jiangsu | Withdrawn |
| Novartis Investigative Site | Beijing | China | Active Not Recruiting |
| Novartis Investigative Site | Beijing | China | Active Not Recruiting |
| Novartis Investigative Site | Shanghai | China | Withdrawn |
| Novartis Investigative Site | Bordeaux | France | Recruiting |
| Novartis Investigative Site | Paris | France | Recruiting |
| Novartis Investigative Site | Paris | France | Recruiting |
| Novartis Investigative Site | Rouen | France | Recruiting |
| Novartis Investigative Site | Toulouse | France | Recruiting |
| Novartis Investigative Site | Tours | France | Recruiting |
| Novartis Investigative Site | Essen | Germany | Recruiting |
| Novartis Investigative Site | Kiel | Germany | Recruiting |
| Novartis Investigative Site | Ranica | BG | Recruiting |
| Novartis Investigative Site | Milan | MI | Recruiting |
| Novartis Investigative Site | Roma | RM | Recruiting |
| Novartis Investigative Site | Matsumoto-shi | Nagano | Recruiting |
| Novartis Investigative Site | Iruma-gun | Saitama | Recruiting |
| Novartis Investigative Site | Bunkyo Ku | Tokyo | Recruiting |
| Novartis Investigative Site | Santiago Compostela | A Coruna | Recruiting |
| Novartis Investigative Site | Barcelona | Spain | Recruiting |
| Novartis Investigative Site | Córdoba | Spain | Recruiting |
| Novartis Investigative Site | Málaga | Spain | Recruiting |
| Novartis Investigative Site | Seville | Spain | Recruiting |
| Novartis Investigative Site | Valencia | Spain | Recruiting |
| Novartis Investigative Site | Izmir | Balcova | Withdrawn |
| Novartis Investigative Site | Köseköy | Kocaeli | Recruiting |
| Novartis Investigative Site | Ankara | Yenimahalle | Recruiting |
| Novartis Investigative Site | Mersin | Yenisehir | Recruiting |
| Novartis Investigative Site | Glasgow | Scotland | Recruiting |
| Novartis Investigative Site | Newcastle upon Tyne | Tyne and Wear | Recruiting |
| Novartis Investigative Site | London | United Kingdom | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05935215 on ClinicalTrials.gov ↗ ← All trials in Italy